EDF Health

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, FDA, Health Policy, Public Health, Unleaded Juice / Read 1 Response

Introducing Deep Dives—EDF’s New Platform for In-Depth Scientific & Policy Analyses on Environmental Health

What’s New? Today we’re launching a new digital channel for the die-hard science and policy wonks in our midst! Deep Dives is a new, long-form blog site that will offer readers in-depth scientific analyses, hard data, and practical policy prescriptions from our top environmental health experts. The authors are Environmental Defense Fund experts in air quality, chemistry, epidemiology, law, public health, and more.Illustration of a pink brain wearing glasses on a bright yellow background

Why It Matters: We have multiple audiences for our content—and data tell us they have very different information needs and preferences about format.

We are committed to giving everyone the information they want in the format they prefer—and that led us to create Deep Dives.

Here’s the Deal: On average, only about 5% of web visitors read to the bottom of any particular piece of internet content. That’s why we have moved this blog to short-form content that tells you what’s happening and why it’s important from the jump. We give you the gist, and we try to keep it under 500 words.

But we also have a specialized audience of scientists, policymakers and implementers, academics, and advocates who value the policy nuances and scientific details. The people in this group want the meaty content and all the details—and, if they are interested in the subject, they will read to the end of the post, no matter how long it is.

If that describes you, Deep Dives was conceived and created for you!

What’s Next? We may be creating a new space for the self-described geeks and wonks, but we’ll continue to give you the skinny here—and all visitors are welcome in both spaces! Be sure to subscribe to this blog to receive email notifications of new Deep Dives blogs.

Last one in is a rotten egg!


Illustration of two French bulldogs under water, wearing swimming goggles, surrounded by a colorful coral reef.

Welcome to our new Deep Divers!

Also posted in Deep Dives, Health Policy, Public Health / Comments are closed

EPA Should Address Cumulative Risks from New Chemicals

Names of blog authors: Maria Doa, PhD, Sr. Director, Chemicals Policy, and Lariah Edwards, PhD, Associate Research Scientist, Columbia University

What’s Happening? EPA’s current safety assessments of new chemicals proposed for market entry often fall short of effectively protecting all members of the public from risk because they don’t consider that we may be exposed to closely related chemicals that cause similar harms.

Recent Example: EPA proposed rules requiring notification of significant new uses for a group of new chemicals. Two of these chemicals, known as trimellitate esters, are very closely related, and would be expected to cause very similar harms and have very similar uses—so that people exposed to one chemical would likely be exposed to the other. Despite this, EPA did not consider the chemicals together or even use the information it had on one to inform its understanding of the safety of the other.

This doesn’t make sense.

Even though EPA said that one chemical was intended to be used as a lubricant and the other as a plasticizer (a chemical that makes plastics more flexible), it is likely that both could be used as a plasticizer or a lubricant. They may be used together or turn up in similar consumer products, such as a car’s dashboard. Further, both chemicals are very closely related to yet another plasticizer used in the auto industry, but it appears that EPA considered these nearly interchangeable chemicals in isolation from one another.

Items that require plasticizers for production. They include seats in cars, rain boots, a garden hose, medical gloves, an exercise ball, and rolls of wallpaper.

In fact, under the Toxic Substances Control Act (TSCA), EPA is required to identify such “reasonably foreseen uses,” such as ending up in the same product.

Why It Matters: Evaluating chemicals in isolation likely underestimates the exposures and risks workers, consumers, and frontline communities face. Doing so also fails to make use of all the best available science, since information on each of these two chemicals (as well as the one already being used) could inform the safety determination for the other.

Considering the combined risks from similar chemicals is not new. EPA is already doing this for another group of closely related chemicals—phthalates. Phthalates have long been widely used in a range of consumer products and are detected in almost all our bodies. Phthalates are known to impact male reproductive health. EPA is joining the ranks of other federal agencies that have considered the cumulative risks they pose.

Our Take: EPA should not stop at phthalates. They can and should be incorporating cumulative approaches from the very beginning of a chemical’s regulatory life. Considering the impact of combined exposures does not need to be complicated and EPA could make such a consideration without much extra effort.

EPA can take a first step toward doing this by considering the potential for cumulative risks when finalizing its regulation on the significant new uses for these two new closely related chemicals.

Go Deeper: Read EDF’s response to EPA’s proposed new SNURs. And check out our Cumulative Risk Assessment Framework.

Also posted in Environment, Industry Influence, Public Health, TSCA / Comments are closed

Sperm Concerns: Sons Affected by Mom’s Exposure to Forever Chemicals

Illustration of gray sperm swimming toward a dark purple egg on a light purple background

By Lauren Ellis, MPH, Research Analyst, Safer Chemicals

What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.

It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.

Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.

This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.

Key Lessons from the Study:

  • Women who were pregnant 20+ years ago had multiple types of PFAS in their blood. The study used data on a group of Danish women who were pregnant between 1998-2003. The women gave blood samples, which were then frozen and stored; 95% of those samples were taken in the first trimester of pregnancy.
  • In 2020-2021, researchers tested those maternal samples for 15 different PFAS compounds. They found 7 of the 15 in the bloodstream of nearly 90% of mothers in the study. The seven were: PFHxS, PFHpA, PFOA, PFOS, PFNA, PFDA, and PFUnDA.
  • Exposure to PFAS during pregnancy decreases the sperm quality of adult male offspring. Researchers found that both combined and single exposure to maternal PFAS concentrations during early pregnancy had a negative effect on the sperm quality—particularly sperm count, concentration, and movement—of adult male offspring.

Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.

Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.

It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.

Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS  that accumulate in the body. That petition is still under review.

Also posted in Emerging Science, Regulation / Tagged , , , | Comments are closed

The many ways the American Chemistry Council wants to turn back time on TSCA implementation – Part 1

Part 1 of a 2-part series: Minimizing or ignoring chemical risks

Maria Doa, Ph.D., Senior Director, Chemicals Policy 

In its recently issued ‘State of TSCA’ report, the American Chemistry Council (ACC) tries to turn back the clock on how EPA assesses and mitigates the risks of toxic chemicals. The chemical industry group looks to return to the policies of the Trump years – a time rife with scientific integrity issues and wholesale disregard of risks – particularly those risks to frontline communities, workers and other vulnerable groups: the very groups the Toxic Substances Control Act (TSCA) calls out for special consideration.

This 2-part blog series looks at the six ways ACC hopes to turn back time on chemical safety and looks at the harms that would result if trade group’s self-serving ideas were to be adopted. Part 1 looks at the types of risks ACC wants EPA to exclude from its chemical risk evaluations, the workers and other groups whose health would be affected, as well as the trade group’s goal to have itself appointed as the arbitrator of EPA science. Part 2 looks at ACC’s efforts to dictate the process for assessing new chemicals and industry’s clear goal to avoid paying its fair share of the cost to evaluate the risks posed by some of the most dangerous chemicals already in the marketplace.  Read More »

Also posted in Health Policy, Industry Influence, Worker Safety / Tagged , , , | Comments are closed

Environmental racism exists in our beauty products and must be addressed

Jennifer Ortega, Research Analyst, Environmental Health

Environmental racism is everywhere. At the neighborhood level, communities of color often experience worse air quality, fewer green spaces, or face more extreme temperatures. At the household level, families of color and low-income families experience a higher risk of lead in their drinking water and higher utility debt and energy insecurity. Inequities are even manifested in the items we use every day, with personal care products marketed to women of color often containing more toxic ingredients than those marketed to white women.

These toxic exposures are not driven by individual choices, but rather by where one lives, where one works, and by cultural beauty standards and norms. A new personal care product story map (also available in Spanish) consolidates federal labor and census data, as well as information from public health studies to show how the intersection of different factors manifests in racial disparities in the exposure to toxic ingredients in personal care products.  The map is part of an interactive web series, led by Tamarra James-Todd, Ph.D., and her team at Harvard T.H. Chan School of Public Health. Read More »

Also posted in Industry Influence, Markets and Retail, Public Health / Tagged , , , | Comments are closed